Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10521450serious1Date Last Updated16/10/2014receiptdateformat102companynumbGB-RANBAXY-2014RR-86630occurcountryGBduplicate1Date Received16/10/2014transmissiondate28/05/2015primarysourcecountryGBseriousnessdisabling1

Primary Source

reportercountryGBqualification3

Patient

Onset Age22Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionErectile dysfunctionOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.0ReactionArthritisOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionVitreous floatersOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.0ReactionAlopeciaOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductISOTRETINOINdrugauthorizationnumb076041drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate28/05/2014drugenddateformat102drugenddate30/08/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application Number NDA211913, NDA021951, ANDA202099, ANDA076356, ANDA076135, ANDA075945, ANDA076485 ... Brand Name ABSORICA LD, ABSORICA, ZENATANE, ACCUTANE, CLARAVIS, ISOTRETINOIN, AMNESTEEM, MY ... Generic NameISOTRETINOINManufacturers Sun Pharmaceutical Industries, Inc., Dr. Reddy's Laboratories Limited, JG Pharma ... product_ndc 10631-002, 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 106 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI 197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ... spl_id a8d4793a-5043-40e1-b623-35812733499f, 1f5178c1-0f6f-824d-d0ee-1b973377ccc6, a599 ... spl_set_id 3ef0cff8-19c1-4441-b780-fca6c7ee1615, 27b3cf26-f22e-5b70-1c24-009933b7c6ee, a41c ... Package NDC 10631-115-69, 10631-115-31, 10631-116-69, 10631-116-31, 10631-117-69, 10631-117- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

Report Duplicate

duplicatesourceRANBAXYduplicatenumbGB-RANBAXY-2014RR-86630

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use